Elekta IMF (Isocentric Mounting Fixture) 1177000EZ

GUDID 05060608880638

Accessory to the 1177 MapCHECK2 .

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880638
• NIH Device Record Key: b929544c-933b-440f-bea4-b52cbc8cb305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elekta IMF (Isocentric Mounting Fixture)
• Version Model Number: 1177000EZ
• Catalog Number: 1177000EZ
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131466

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [Elekta IMF (Isocentric Mounting Fixture)]

• B0161177000EZ0: Accessory to the 1177 MapCHECK2 .
• 05060608880638: Accessory to the 1177 MapCHECK2 .